# K123597: Truecpr Coaching Device

- Pathway: 510(k) (Traditional)
- Applicant: Physio-Control, Inc.
- Decided: Apr 17, 2013 after 147 days
- Product code: LIX (Aid, Cardiopulmonary Resuscitation)
- Device class: 2
- Regulation: 21 CFR 870.5210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071321 (2007). 3 ancestors in all.
No later device cites it as a predicate yet.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112660: Pocketcpr, Zoll Medical Corp (2012) Summary page 1.
- K071321: Pocketcpr, Bio-Detek, Inc. (2007) Summary page 1.
- K051134: Heartstart MRX with Q-CPR Option, Models M3535A or M3536A, Philips Medical Systems (2005) Summary page 1.

## Indications for use
The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.

Source page: https://510kreport.com/device/K123597
Methodology: https://510kreport.com/methodology